MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ASPIRATOR,SUCTION,W/850CC CANISTER

Catalog Number	HCS7001
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the products were "returned from the field and went through the cleaning procedure" they developed "poor and intermittent suctioning".
Additional Manufacturer Narrative
The customer reported that after the products were "returned from the field and went through the cleaning procedure" they developed "poor and intermittent suctioning" and that the incidents did not occur while using on a patient or individual.A sample was received for investigation; the sample was visually inspected with no external physical damage observed, plugged into a power source and turned on, and the control dial was turned to the maximum setting, where the pressure was observed to be 600 mm hg and met product specifications.Medline could not confirm the issue of the device having poor suction and could not confirm the product failed to meet specifications.The cause was not confirmed with the received sample, and the quality team will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: ASPIRATOR,SUCTION,W/850CC CANISTER
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50868467
• Report Number: 1417592-2026-48721
• Device Sequence Number: 10673984
• Product Code: BTA
• UDI-Device Identifier: 10193489036381
• UDI-Public: 10193489036381
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: HCS7001
• Device Lot Number: 6462311
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown